The build vs buy conundrum for businesses is not new when it comes to decisions around implementing new software. For drug sponsors, regulatory requirements to manage the long-term archival of the eTMF presents a business challenge with a number of different solutions.
Data storage is something that every organisation contends with, but when digital assets need preserving for decades, specialist services are required. These can in theory be built internally although external options may provide a low risk and simple solution.
The case for ‘build’
Most engineers want to build software so they can own and understand it and ensure that it meets their business’ needs. Even when a solution is bought, they often want or need to develop or customise it in some way.
A good rule of thumb is that if an off-the-shelf solution doesn’t immediately meet 80% of a business’ needs, then it’s unlikely to be worth buying as it will likely still need functionality to be developed for the missing requirements, negating any efficiency savings. Existing and planned capabilities in relation to eTMF archival must be carefully considered by a business to make sure any solution meets their requirements.
The question to ask here is whether the functionality is part of the core of the business and would genuinely add value. When it comes to meeting regulatory requirements, the desire in the pharma industry is often to implement a minimal viable solution and realise broader potential and additional value at a later stage. If a solution can do both off-the-shelf, the business case for internal development is often weakened.
The case for ‘buy’
A number of challenges arise when setting up an in-house eTMF archive and the case for buying a solution is broadly covered by 4 core arguments:
1) Specialist archiving and preservation automated tools and processes (aligning to best practice and industry standards)
With eTMF archival, there are rigorous compliance requirements which create additional pressures for IT and engineering departments. A solution has to be developed and validated with no room for error.
Automatically preserving files in their latest format and automated ‘fixity’ checks, which periodically test to see if any data has become corrupted or damaged, are essential features. They ensure a device many years into the future will still be able to access that information.
It is these types of processes that ensure compliance with regulatory requirements, especially in relation to GxP data integrity, accessibility, readability and usability for the retention periods mandated.
2) Domain expertise
There is also complexity and nuance when it comes to archival that specialist providers have a wealth of experience in dealing with. Archival is different to storage and dedicated solutions go far beyond storage or data backup and provide a range of archiving and preservation processes to ensure that the data is findable, accessible and usable for as long as it needs to be retained – this is at least 25 years in the EU.
3) Fully validated solutions with a focus on QMS
Solution providers who are experienced in offering services to regulated customers regularly release validated versions of their software and ensure support for their QMS processes. This can remove risk and uncertainty about the new solution and ease onboarding.
Arkivum further de-risks outsourcing with its no-vendor-lock-in approach. With our solution, the eTMF is stored in 3 locations, the third of which is in ESCROW which simplifies the transfer of data and ensures life science companies maintain absolute control of their data.
4) Resource efficiency
The decision to buy is heavily influenced by whether an internal team can deliver the same solution and value – taking into account not just engineering costs, but the ongoing costs post-development and testing, including validation, support and checks.
This also leads into a discussion on resource efficiency. To innovate and develop processes and systems that solve business needs, IT departments and engineers need to dedicate their time to such endeavours. Reworking existing services may not be the best use of their time when they can simply buy a product that solves a business requirement.
Bought solutions are likely to reduce deployment time and more often than not the vendor will add domain expertise and support services to underpin their offering which can significantly lower costs in the long term.
Deciding on the right approach for your business
The decision on whether to buy or build isn’t always as straight forward as we’d all like it to be but it’s important that you take your time to fully evaluate what your organisation’s requirements are for your archiving solution. Once you’ve answered this question then you need to understand how these match with your organisation’s internal capabilities.
Whilst we can’t decide the best route for you to take, we wouldn’t recommend building an eTMF archiving solution in-house if your organisation:
- Doesn’t have the internal resource or capability to be able to build a solution.
- Has limited experience in digital archiving and preservation solutions.
- Cannot guarantee compliance with eTMF archiving regulatory guidance.
- Cannot ensure the readability and usability of your clinical data for over 25 years.
Arkivum provides validated digital archiving support and software for document tracking. Our experienced team is ready to protect your critical data and guarantee that it is accessible, secure, reliable, and immutable – now and in the future.
To learn more about how we deliver complete data integrity and data preservation for the long term, book a demo today.
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